510(k) K254168
- Device
- Actolind® (06.3637. Actolind® Gel Plus)
- Applicant
- ACTO GmbH
- 510(k) number
- K254168
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-22
- Date received
- 2025-12-23
- Classification name
- Dressing, Wound, Drug
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Ahmet Kilic
- Address
- Büchnerstrasse 11 - 38118 Braunschweig Schulstrasse 8 - 31613 Wietzen-Holte Braunschweig DE 38118 38118
FDA Registration Numbers#
- 3017297225
- 3006784948
- 2135339
- 3010160527
- 3014004349
- 1921846
- 1819174
- 1222747
- 3024856793
- 3010610950
- 3016678045
- 1423537
- 3019543072
- 3000268902
- 3009655869
- 3007963765
- 3022754162
- 1038758
- 1221816
- 3003418325
- 3012979524
- 3018348
- 1314417
- 3004018264
- 3042272797
- 3019944216
- 3023994877
- 3008396914
- 3004681519
- 3013820501
- 1061124
- 3011210302
- 3010288357
- 1025483
- 3006984486
- 3008562678
- 3033530347
- 9616088
- 3007648359
- 3012535730
- 1720734
- 3011238790
- 3010155648
- 3010770024
- 3031841433
- 3021784063
- 3007125968
- 3016504086
- 3019843904
- 3017396949
- 3013582868
- 2245590
- 3013478891
- 3006802076
- 3015142802
- 3011191255
- 3026544741
- 3016450032
- 3005669815
- 3004554409
- 3034456223
- 1220246
- 1720929
- 3008032237
- 3012973796
- 3038356900
- 1066368
- 3012494290
- 1018120
- 3008808082
- 3010763707
- 3001186500
- 8043484
- 3013557562
- 1219103
- 3006052875
- 1047843
- 9710608
- 9680357
- 1480288
Source Documents#
Other 510(k) Records For Product Code FRO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254041 | SkinSmart Antimicrobial HydroGel | Magic Science Supply, LLC | 2026-09-11 |
| K261646 | Redermax® Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-08-14 |
| K253665 | Vashe Plus Antimicrobial Solution | Urgo Medical North America, LLC | 2026-08-11 |
| K251929 | SilverCeuticals® Antimicrobial Wound Gel | Silverceuticals, Inc. | 2026-06-24 |
| K261023 | Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | 2026-06-24 |
| K261638 | Bonvadis® | Oneness Biotech Co., Ltd. | 2026-06-17 |
| K254073 | StatSeal Disc | Merit Medical Systems, Inc. | 2026-05-13 |
| K254191 | IWD-Gel™ | InnovaCorium, Inc. | 2026-04-07 |
| K252023 | MiraChlor Antimicrobial Wound Solution | Letus Corporation | 2026-03-25 |
| K251999 | Promogran Prisma™ Collagen Matrix with ORC and Silver | Solventum Germany GmbH | 2026-03-13 |
| K252028 | LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. | 2026-03-11 |
| K251582 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-02-02 |
| K252568 | New Day Skin Spray | Silk Holdings, Inc. | 2026-01-23 |
| K250890 | SBC1 Cream | Sioxmed, LLC | 2026-01-12 |
| K252759 | revyve® Antimicrobial Skin and Wound Cleanser | Kane Biotech, Inc. | 2026-01-08 |